FDA.reportPublic FDA data

EKOS Corporation

Matched from indexed company URL: Ekos Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30016274573001627457EKOS Corporation1Y2020-04-2511911 N. Creek Parkway South Bothell WA US 98011

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858593006493EkoSonic® - The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device.888-400-3567EKOSCustomerService@ekoscorp.com
00858593006509EkoSonic® - The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter and Ultrasonic Core to the Control Unit.888-400-3567EKOSCustomerService@ekoscorp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2339071033164399K191119EkoSonic Endovascular DeviceQEY2019-08-23
2339071072972242K183361EkoSonic Endovascular Device with Control Unit 4.0QEY2019-04-05
2339071950019767K182324EkoSonic Endovascular SystemQEY2018-11-26
2339071237276352K162771EkoSonic Endovascular System with Control Unit 4.0QEY2017-02-24
2339071276178784K140151EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNITQEY2014-05-21
2339071648454954K111705EKOSONIC ENDOVASCULAR SYSTEMQEY2011-08-03
2339071485509661K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONQEY2008-06-26
2339071696382194K052435PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITSKNW2005-11-03
2339071695359811

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEY72019-08-23
KNW12005-11-03

PMN#

GUDID#